BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 3001641 · Received February 26, 2013

    Report

    Report Number
    8010047-2013-00068
    Event Type
    Death
    Date Received
    February 26, 2013
    Report Date
    January 31, 2013
    Manufacturer
    OLYMPUS MEDICLA SYSTEMS CORP
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, AND WAS INFORMED THAT THE SUBJECT BRONCHOSCOPE WAS USED TO ASSIST IN AN INTUBATION PROCEDURE. THE SUBJECT DEVICE WAS SAID TO HAVE BEEN USED WITH TWO SMITH MEDICAL TRACHEAL TUBES (PORTEX7 AND PORTEX8). THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED USING THE SAME BRONCHOSCOPE, BUT THE PT REPORTEDLY EXPIRED AFTER THE PROCEDURE. THE CAUSE OF DEATH IS UNK AND THE USER FACILITY INDICATED THAT THEY DO NOT SUSPECT THE BRONCHOSCOPE TO BE THE CAUSE OF THE PT'S OUTCOME. NO FURTHER INFORMATION WAS PROVIDED. THE EVALUATION OF THE SUBJECT BRONCHOSCOPE CONFIRMED THAT THE BENDING SECTION COVER WAS FOUND TO BE STRETCHED, WHICH CAUSED THE BENDING SECTION COVER TO FOLD BACK FROM THE DISTAL END. BASED ON THE INVESTIGATION WITH THE USER FACILITY THE SUBJECT BRONCHOSCOPE WAS BEING REPROCESSED IN A STERIS SYSTEM 1E, WHICH IS AN AUTOMATED ENDOSCOPE REPROCESSOR THAT OLYMPUS DOES NOT RECOMMEND OR SUPPORT. THE BRONCHOSCOPE WAS SERVICED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE PT OUTCOME REMAINS UNK. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY RETURNED THE SUBJECT BRONCHOSCOPE TO OLYMPUS FOR SERVICE DUE TO A DAMAGED BENDING SECTION RUBBER. THE USER FACILITY ASL REPORTED THAT THE SUBJECT BRONCHOSCOPE FAILED DURING A PROCEDURE, AND WAS INVOLVED IN PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81491 OLYMPUS BRONCHOSCOPE EOQ OLYMPUS MEDICLA SYSTEMS CORP BF-1T60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TRACHEAL TUBE